Rituximab - Immunotherapy for Schizophrenia Spectrum Disorder in Adults: An Open Pilot Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Positive and Negative Syndrome Scale (PANSS)
研究概览
简要总结
This study evaluates the addition of rituximab to 12 patients diagnosed with treatment resistant schizophrenia spectrum disorder in an open trial.
详细描述
Immunological factors may be determinants for some psychiatric disorders, thus immunomodulation may be helpful. Rituximab (antibodies against CD20, cluster of differentiation), a standard treatment for multiple sclerosis, is an anti-inflammatory drug, hitherto not tested for psychiatric disorders.
The aim of this study is to investigate whether the psychiatric symptoms of treatment-resistant adult psychiatric patients, diagnosed with schizophrenia spectrum disorder (SSD), are significantly improved after treatment with rituximab. Our purpose is to implement recent insights from "Immunopsychiatry" to find efficacious, but still tolerable treatment for these patients.
This is a single-site, 20-week, open pilot, add-on treatment as usual, trial, where the patients will be followed for 1 year.
Rituximab will be administered with one single dose of 1000 mg. Investigators will analyse inflammatory and metabolic biomarkers in relation to the primary outcome, treatment response (defined as clinically relevant reduction in the validated measure PANSS). Other outcomes are "much" or "very much improved" on Clinical Global Impression - Improvement scale (CGI-I) and change in Personal and Social Performance Scale measuring overall disability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •on-going immunomodulatory treatment
- •pregnancy or breast-feeding
- •weight below 40 kg
- •clinically relevant on-going infection
- •chronic infections
- •positive screening test for hepatitis B, C, HIV or tuberculosis
- •any change of psychotropic medication within the previous 4 weeks
- •"much" or "very much improved" already at baseline according to CGI-I i.e. scores of 1 or 2 by the clinician
- •severe heart failure (NYHA grade IV) or other severe heart disease or history of cardiac arrhythmia or myocardial infarction
- •unable to make an informed decision to consent to the trial
- •in compulsory treatment
- •treatment with clozapine within the last 2 months
- •previous treatments with immunosuppressive agents
- •malignancy currently or within 2 years prior to inclusion
研究组 & 干预措施
Rituximab
1000 mg of rituximab, infusion once
干预措施: Rituximab (Drug)
结局指标
主要结局
Positive and Negative Syndrome Scale (PANSS)
时间窗: week 20
Change in symptoms measured as change in Positive and Negative Syndrome Scale (PANSS) score from baseline. PANSS measures symptom severity of patients with schizophrenia and is a clinically based interview. PANSS measures positive symptoms (7 items, range 7-49), which refer to e.g. hallucinations and delusions; negative symptoms (e.g. loss of normal functions) (7 items, range 1-7) and general disability (16 Items, range 16 -112) separately. Higher scores denote more symptoms and disability. PANSS total score range from 30-210. At least 40 % reduction in PANSS total score is regarded as response.
次要结局
- Personal and Social Performance Scale (PSP)(week 20)
- Clinical Global Impression-Severity (CGI-S) Scale(week 20)
- Clinical Global Impression-Improvement (CGI-I) in Relation to Inflammatory Markers(week 20)
- Clinical Global Impression-Improvement (CGI-I). Proportion of Responders.(week 20)
- Clinical Global Impression-Improvement (CGI-I).(week 20)
- Adverse Event: Any Adverse Reactions (AAR). Safety and Tolerability of Rituximab(week 20)
研究者
Susanne Bejerot
Professor
Region Örebro County